Utility of Brexanolone to Target Stress-induced Alcohol Use Among Men and Women With Posttraumatic Stress Disorder

NCT05223829 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 2000031354U54AA027989
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

For this protocol, the investigators plan to collect pilot data to: 1. establish the feasibility and safety of administering brexanolone to individuals with concurrent Posttraumatic Stress Disorder (PTSD) and Alcohol Use Disorder (AUD).

Conditions

PTSD; Alcohol Use Disorder

Keywords

alcohol; brexanolone; PTSD

Outcome Measures

Primary Outcomes (1)

• Treatment-emergent adverse events

  Treatment-emergent adverse events will be assessed following administration of brexanolone.

  30 days following administration of brexanolone

Study Arms (1)

Brexanaolone

EXPERIMENTAL

In this single-arm study, participants will be administered brexanolone as a continuous IV infusion over 20 hours (titrated up to 90mcg/kg/hour).

Drug: Brexanolone

Interventions

Brexanolone DRUG

Brexanolone will be administered as a continuous IV infusion over 20 hours under medical observation

Also known as: Zulresso

Brexanaolone

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged 21-55 years old
• Meet DSM-5 diagnostic criteria for AUD within the past 6 months, as well as the following drinking criteria:
• Men: drink greater than 14 drinks per week and exceed five drinks per day at least once per week within the past 30 days
• Women: drink greater than 7 drinks per week and exceed four drinks per day at least once per week within the past 30 days
• Meet DSM-5 diagnostic criteria for PTSD in the past 6 months

You may not qualify if:

• Actively seeking treatment for AUD
• Likely to experience clinically significant alcohol withdrawal during the study procedures (e.g., history of alcohol-related perceptual distortions/hallucinations, seizures, or Clinical Institute Withdrawal Assessment Scale score \> 8 at intake)
• Current (i.e., past month) active suicidal ideation and/or homicidal ideation
• Meets DSM-5 diagnostic criteria for schizophrenia, bipolar disorder, and/or other severe mental illnesses.
• Meets criteria for current (past 6 months) substance use disorders (other than tobacco use disorder).
• Tests positive for illicit substances during urine toxicology screens (except cannabis) at intake session
• Is actively engaged in psychotherapy to treat PTSD
• Any significant current medical conditions (neurological, cardiovascular \[including hypertension or hypotension: sitting BP \>160/100 or \<90/60mmHg at baseline screening\], endocrine, thyroid, renal, liver), seizures, delirium or hallucinations, or other unstable medical conditions including HIV
• Past 30 day use of psychoactive drugs including anxiolytics and antidepressants.
• Women who are pregnant or nursing, or fail to use one of the following methods of birth control unless she or her partner is surgically sterile or she is postmenopausal (hormone contraceptives \[oral, implant, injection, patch, or ring\], contraceptive sponge, double barrier \[diaphragm or condom plus spermicide\], or IUD)
• Subjects likely to exhibit clinically significant alcohol withdrawal during the study. Specifically, we will exclude subjects who a) have a history of perceptual distortions, seizures, delirium, or hallucinations upon withdrawal or b) have a score of \> 8 on the Clinical Institute Withdrawal Assessment scale at intake appointments.
• Participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current application

Sponsors & Collaborators

• Yale University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• Sage Therapeutics: collaborator

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Alcoholism

Interventions

brexanolone

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• MacKenzie R Peltier, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Model Details: This project is a Phase 1 (open-label, single arm, proof of concept) laboratory design. It will investigate the feasibility and safety of administering brexanolone to men and women and collect preliminary data to understand brexanolone's efficacy to reduce stress-induced drinking in individuals with PTSD/AUD.

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: February 4, 2022
• Study Start: August 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)